A project is available for a fellowship in the Office for Human Research Protections (OHRP). OHRP provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and social-behavioral research.
OHRP’s Division of Compliance Oversight (DCO) evaluates, at OHRP’s discretion, written substantive indications of noncompliance with HHS regulations—Title 45, Part 46, Code of Federal Regulations (45 CFR 46). OHRP asks the institution involved to investigate the allegations and to provide OHRP with a written report of its investigation. The Office then determines what, if any, regulatory action needs to be taken to protect human research subjects. DCO also conducts a program of not-for-cause surveillance evaluations of institutions, and receives, reviews, and responds to incident reports from Assured institutions.
The fellow will assist in:
• Conducting in-depth compliance oversight investigations including compiling, reviewing, and evaluating investigative materials and preparing investigative reports;
• Responding to technical questions, problems and policy issues encountered by other members of the team;
• Coordinating investigative teams for site visits and assisting others with this task;
• Recommending to senior OHRP staff corrective actions regarding noncompliance;
• Evaluating indications of noncompliance with HHS regulations at 45 CFR part 46 and processing reports of unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, and suspension or termination of IRB approval, and preparing outgoing correspondence in response.
• Accurately reporting research protection information and data to diverse audiences.
Participants will continue to increase their understanding and experience of key strategic issues related to health and human research protections. Participants will have opportunities to interact with other Federal agencies and non-governmental groups on research issues.
The Research Participation Program for DHHS is administered by the Oak Ridge Institute for Science and Education (ORISE). The initial appointment is for one year, but may be renewed upon recommendation of OHRP contingent on the availability of funds and project needs. The participant will receive a monthly stipend based on educational level and experience. The participant must show proof of health insurance. The appointment is full-time at OHRP in the Rockville, Maryland, area. Participants do not become employees of OHRP, DHHS, or the program administrator, and there are no fringe benefits paid.
Applicants will have earned a Bachelor’s, Master’s or Doctorate degree in public health, public policy, science, law, ethics, philosophy, or related fields within the last five years. A focus on health, as well as research experience, is beneficial.
Further information about OHRP’s programs, projects and activities can be found at: http://www.hhs.gov/ohrp/index.
How to Apply:
Research participation for the Department of Health and Human Services is administered by the Oak Ridge Institute for Science and Education. To be considered, please send a cover letter stating your interest, CV/resume, writing sample and the names and contact information for three persons who will provide references for you to DeAnna Copeland at DeAnna.Copeland@orau.org. Please reference Project # DHHS-OHRP-2013-0102 in all communications.
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